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Completed

NCT Number: NCT05797532

Comparison of Different Methods for Reducing Pain in Heel Blood in Newborns

Newborns are exposed to painful invasive procedures from the first hours of their lives. It is stated that the functional and anatomical structure of the neural pathways of newborns with many systems immature develops well enough to feel pain and they have the ability to remember after experiencing pain. Physiological symptoms (increase in heart rate and blood pressure, increase in oxygen saturation, etc.) as a result of painful procedures (vascular or heel lance collection, venous or arterial catheterization, subcutaneous and intramuscular injection, chest tube insertion, intubation, aspiration, etc.) applied for diagnosis and treatment in newborns. falling), crying behavior and metabolic problems. In conclusion, the energy resources required for the growth and development of newborns are used to cope with pain, and it is reported that repetitive painful procedures increase mortality and morbidity in newborns.

Heel lance, which is applied to all newborns within the scope of the newborn screening program, is one of the painful invasive procedures for newborns. Heel lance should be taken as capillaries in the first 48 hours after feeding or until the first week of life of newborns. In the literature, non-pharmacological methods applied to reduce the severity of pain felt by newborns during heel lance, which also causes tissue integrity deterioration; It has been observed that studies examining the effects of breast milk, swaddling, holding, breastfeeding, music, oral sucrose, non-nutritive sucking, skin-to-skin contact (SSC) and positioning. SSC, breastfeeding and swaddling + holding methods are among the methods that can be easily used by mothers and nurses. Nurses working in the maternity ward where heel lance sampling is performed in the hospital have a key role in reducing the pain level of newborns by collaborating with the families of the babies.

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Key information

Conditions

Pain Behavior Breast Feeding Feeding Behavior Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

24 hour–36 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Sciences University

Kütahya, Turkey (Türkiye)

About this study

This study was conducted to compare three different methods (breastfeeding, skin-to-skin contact, swaddling + holding) in reducing the pain felt during routine heel lance from term newborns within the scope of the National "Newborn Screening Program" of the Ministry of Health.

Hypotheses; H1: Breastfeeding method is more effective than skin-to-skin contact and swaddling + holding methods in reducing pain due to heel lance in newborns.

H2: Skin-to-skin contact method is more effective than breastfeeding and swaddling + holding methods in reducing pain due to heel lance collection in newborns.

H3: Swaddling + holding method is more effective than breastfeeding and skin-to-skin contact methods in reducing the pain associated with heel lance collection in newborns.

Statistical power analysis was performed at the end of the study in line with the data collected from a total of 90 newborns, 30 of whom were in each study group. The power of the study was found to be 0.81 - 0.99 at the alpha = 0.05 significance level, and the effect size was between 0.02 and 0.68.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Newborns (0-28days);

  • Being born at term (38 - 42 weeks)
  • Stable vital signs
  • Having completed the first 24 hours of life and being fed
  • Heel blood procedure will be applied for the Ministry of Health screening.
  • Not being breastfed 30 minutes before the procedure
  • No previous invasive intervention other than vitamin K and hepatitis B vaccine.
  • 1st and 5th minute Apgar score ≥7
  • Parents have given written consent.

Exclusion criteria

Newborns (0-28days);

  • Unstable vital signs
  • Being bottle-fed or formula-fed
  • Having a neurological diagnosis
  • Prior exposure to another invasive procedure other than vitamin K and hepatitis B vaccine.
  • Maternal use of opioids,
  • Not being born at term.

Treatment and study plan

breastfeeding

Other

The NIPS (Neonatal Infant Pain Scale) pain score, heart rate and oxygen saturation of the newborn were recorded by the researcher in the study group, 2 minutes before the heel lance, 10 seconds during the heel lance, and 2 minutes after the heel lance was completed.

In order to determine the crying time of newborns in all three study groups, the voice recorder and stopwatch were turned on two minutes before and 2 minutes after the heel lance.

skin to skin contact

Other

The NIPS (Neonatal Infant Pain Scale) pain score, heart rate and oxygen saturation of the newborn were recorded by the researcher in the study group, 2 minutes before the heel lance, 10 seconds during the heel lance, and 2 minutes after the heel lance was completed.

In order to determine the crying time of newborns in all three study groups, the voice recorder and stopwatch were turned on two minutes before and 2 minutes after the heel lance.

swaddling and holding

Other

The NIPS (Neonatal Infant Pain Scale) pain score, heart rate and oxygen saturation of the newborn were recorded by the researcher in the study group, 2 minutes before the heel lance, 10 seconds during the heel lance, and 2 minutes after the heel lance was completed.

In order to determine the crying time of newborns in all three study groups, the voice recorder and stopwatch were turned on two minutes before and 2 minutes after the heel lance.

Primary outcomes

  1. Determination of pain scores according to measurement times; before the heel lance procedure, the newborn was 5 minutes after breastfeeding, swaddling and holding, skin-to-skin contact.

    Time frame: through study completion, an average of 6 month

    Neonatal Infant Pain Scale pain score of the newborn were recorded by the researcher in the breastfeeding, swaddling and holding, skin-to skin-contact groups, 2 minutes before the heel lance, 10 seconds during the heel lance, and 2 minutes after the heel lance was completed.

    The lowest score obtained from the scale is 0, and the highest score is 7. A high scale score indicates a high level of pain in the newborn. The scoring of Neonatal Infant Pain Scale ranges from 0-7 points and 0-2 points indicate no pain, 3-4 points indicate moderate pain, >4 points indicate high levels of pain.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 4, 2023
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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